Safety of sedatives in hypothermic ICU patients v4
Research type
Research Study
Full title
Is it safe to use a 12 hour cut off to exclude the effect of sedative agents on clinical examination in Intensive Care Unit (ICU) patients treated with hypothermia post-cardiac arrest?
IRAS ID
178665
Contact name
Fiona J Baldwin
Contact email
Sponsor organisation
Brighton and Sussex Universities Hospital Trust
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
Severe brain injury as a result of a lack of oxygen following cardiac arrest is unfortunately relatively common on the ICU. Early identification of patients with no chance of a good recovery helps to avoid inappropriate treatment and provide information for relatives. There is also the potential for patients with severe brain injuries to go on to donate organs after the withdrawal of life-sustaining treatment. Sedative drugs can significantly impair responses elicited during clinical examination used to assess patients. Currently there is no measurement of drug levels prior to neurological assessment and prognostication and all recommendations are based on theoretical pharmacokinetics in non-ICU populations. A recent Consensus statement from the European Resuscitation Council (ERC) and the European Society of Intensive Care Medicine recommended that for comatose survivors of cardiac arrest prospective studies are needed to investigate the pharmacokinetics of sedative drugs and although recommend waiting 12 hours from stopping sedative infusions before prognostication although acknowledge there is very little evidence for this recommendation.
This is particularly relevant in patients treated with cooling or therapeutic hypothermia (also known as targeted- temperature management) to try and help their brains following cardiac arrest as this prolongs the effects of sedative drugs. The aim of this observational study is to demonstrate either the presence or absence of the two most commonly used drugs, fentanyl or propofol, in the patient’s blood at 12 hours post cessation of infusion of sedative drug infusions and to assess whether the current guidance is safe. The aim is to assay sedative drug levels in this group of ICU patients to allow clinicians to be certain there is no residual drug influencing clinical examination prior to prognostication or organ donation. We will also look at clinical and genetic factors that may influence drug metabolism in this patient group.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
16/LO/0482
Date of REC Opinion
9 Jun 2016
REC opinion
Further Information Favourable Opinion